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BioVie Receives Notice of Allowance for United States Patent Application Covering Novel Liquid Formulation of Terlipressin
Patents covering BioVie’s terlipressin liquid formulation now secured in the United States, India and Chile, and are pending in nine additional markets
About this update from Biovie Inc.
[{"type":"text","content":"Patents covering BioVie’s terlipressin liquid formulation now secured in the United States, India and Chile, and are pending in nine additional markets Formulation has demonstrated room-temperature stability for up to 24 months, representing an important advantage for treating patients with cirrhosis and ascites in the home-care setting CARSON CITY, Nev., Oct. 01, 2024 (GLOBE NEWSWIRE) -- BioVie Inc. (NASDAQ: BIVI), (“BioVie” or the “Company”), a clinical-stage company developing innovative drug therapies for the treatment of neurological and neurodegenerative disorders and advanced liver disease, today announced that it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for patent application no. 17/611,478 entitled \"Formulations of Terlipressin.\" This Notice of Allowance is expected to result in the issuance of a US patent once administrative processes are completed. The allowed claims cover a novel liquid formulation of terlipressin acetate that has stability at room temperature for two years and can be packaged in a pre-filled syringe. BioVie expects the resulting patent will be approved for listing in the Orange Book. The patent supports BioVie’s liquid formulation of terlipressin for development of a more patient-centric ambulatory treatment regimen for patients with ascites and hepatic failure in the US. Patients with cirrhosis and ascites have large volumes of fluid accumulate in the abdomen (often exceeding 5 liters) due to liver and kidney dysfunction. Patients that progress to refractory ascites face a one-year survival rate of approximately 50%1. To date, there is no approved medical therapy specifically for refractory ascites. Management of these patients is based upon procedures such as large-volume paracentesis and TIPS, which only provide temporary relief, lack disease-modifying effects, and lead to frequent life-threatening complications. \"Terlipressin is a drug used in over 40 countries to treat related complications of liver cirrhosis that was only recently approved in the US as a lyophilized powder for in-hospital use, which requires reconstitution with sterile sodium chloride and refrigerated storage conditions for proper administration,” said Cuong Do, BioVie’s President and CEO. “Our novel liquid formulation of terlipressin is stable at room temperature for up ...